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    NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

    The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday. The committee governing the NEST Coordinating Center (NESTcc) approved a four-pronged 2019 action plan, which involves two “key areas” in which NESTcc “has refined its direction.” These relate to developing the NESTcc data network and planning for the center’s own sustainability. ...
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    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...
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    FDA Approves 17th Biosimilar, Third for Herceptin

    The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb) , the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab). In the US, where no Herceptin biosimilar has launched, there are two other competitors: Celltrion’s Herzuma (trastuzumab-pkrb), approved in December 2018, and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017. In Europe, Ontruzant launched in March and ...
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    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...
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    Research Examines Applications of Model-Informed Drug Development

    A new article published in Clinical Pharmacology & Therapeutics digs through case studies, research papers and regulatory documents to highlight some common features of Model-Informed Drug Development (MIDD) applications and future considerations.   The US Food and Drug Administration (FDA) officials from the Office of Clinical Pharmacology explain in the article how MIDD applications can be classified into four categories: dose optimization, supportive evidence for ...
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    FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

    The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...
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    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
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    Mail Order Pharmacies Can Lessen Generic Usage, Study Finds

    Although nearly 90% of all drugs dispensed in the US are now generic drugs, a new study published in Therapeutic Innovation & Regulatory Science explores the determinants of generic substitution across therapeutic classes and found that in five of eight studied classes, patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies. The research, funded by a grant from the US Food and Drug Administration, sa...
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    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
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    FDA Takes Steps to Make Naloxone an OTC Drug

    The US Food and Drug Administration (FDA) on Thursday announced new steps to try to increase the availability of the decades-old opioid overdose antidote naloxone. The announcement comes as more than 72,000 died of opioid overdose deaths in 2017 and as naloxone sales have doubled from about 2.5 million units sold in 2013 to about five million units sold in 2017. And although naloxone is not yet an over-the-counter (OTC) product, CVS told Focus that it has pharmacy ...
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    EU Regulatory Roundup: UK Plans to Add Refrigerated Storage to Mitigate Hard Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Plans to Add 5,000 Pallets of Refrigerated Storage to Mitigate Hard Brexit   The United Kingdom government expects to expand cold chain storage capacity ahead of a potential no-deal Brexit with refrigerated space for 5,000 pallets. Government officials also expect to add 53,000 pallets of ambient storage and 850 pallets of controlled drug storage.   Efforts t...
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    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...